Multiple SclerosisMS-FIRSTNCT04403594
Functional Intermuscular Reduction of Spasticity
An observational study of Multiple Sclerosis, run by University of Oklahoma at 1 site in United States.
Trial summary
Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- dry needling
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 18 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: People with a diagnosis of MS and spasticity
Who may be able to join
- Diagnosis of MS based on MRI
- Ability walk 25 feet
- Spasticity of one lower extremity
Who cannot join
- Blood clot within the last 6 months
- Bleeding disorder
- Active cancer
- Botox in the lower extremities within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
About this study
Official title: Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)
Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation.
Read the detailed description
This study will be the first to combine a novel two-pronged approach to the management of spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease spasticity in an innovative way through dry needling. Second, investigators will follow this spasticity reduction technique using external electrical stimulation applied to the calf, while the participant walks on a harnessed treadmill (for safety). The investigators believe modulating tone in the calf with dry needling will allow for improved strength with electrical stimulation, while simultaneously improving the efficiency of the muscles during walking. The investigators hypothesize that decreasing spasticity will result in enhanced gait efficiency, and lower fatigue, all while allowing the participant to meet their personal mobility goals.10 The investigators are proposing an innovative study design. Assessing changes in muscle spasticity using electromyography and the Modified Ashworth scale before and after each portion of our two-pronged intervention will enable them to understand the immediate effects of dry needling, as well as the combined effects of function electrical stimulation with with treadmill training. Following the intervention assessments with pre-post functional tests will allow us to determine long term changes. This proposal offers a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with the advantage of being minimally invasive and inexpensive. Results of this pilot study will inform the potential use in MS, and will allow for a larger study examining optimal intervention parameters for future use.
- Conditions
- Multiple Sclerosis
- Being tested
- dry needling
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
Also called functional electrical stimulation
dry needling followed by functional electrical stimulation and treadmill training
| Study group | Role | What they receive |
|---|---|---|
| MS with spasticity of one lower extremity | A person diagnosed with Multiple Sclerosis and spasticty of one lower extremity. The person must be able to walk 25 feet and cannot have had Botox in the lower extremity on the last 6 months. Receives: Other: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
distance walked over 6 minutes assessed at the start of the study and after 6 weeks.
Measured: up to 7 weeks
25-foot walk
time to walk 25 feet assessed at the start of the study and after 6 weeks.
Measured: up to 7 weeks
Berg Balance Scale
Balance test conducted at the start of the study and after 6 weeks.
Measured: up to 7 weeks
Modified Fatigue Impact Scale
patient-reported questionnaire collected at the start of the study and after 6 weeks.
Measured: up to 7 weeks
Toe taps on force plate
number of toe taps in 10 seconds counted at the start of the study and after 6 weeks.
Measured: up to 7 weeks
EMG data of both lower extremities
Electromyography (EMG) will be conducted at the start of the study and after 6 weeks. EMG is an electrodiagnostic technique for evaluating and recording the electrical activity produced by skeletal muscles. This is completed using electrodes that are placed on the skin, which detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. These action potentials are measured and recorded on a computer.
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start19 Aug 2019
- Primary completion1 Apr 2021
- Study completion18 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Shirley James, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403594
- Sponsor's protocol ID
- 19-21
- Acronym
- MS-FIRST
- Status last verified
- Sep 2021
- First submitted
- 13 May 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)
- ClinicalTrials.gov ID
- NCT04403594
- Acronym / sponsor ID
- MS-FIRST / 19-21
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Medical Research Foundation
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation.
Detailed description
This study will be the first to combine a novel two-pronged approach to the management of spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease spasticity in an innovative way through dry needling. Second, investigators will follow this spasticity reduction technique using external electrical stimulation applied to the calf, while the participant walks on a harnessed treadmill (for safety). The investigators believe modulating tone in the calf with dry needling will allow for improved strength with electrical stimulation, while simultaneously improving the efficiency of the muscles during walking. The investigators hypothesize that decreasing spasticity will result in enhanced gait efficiency, and lower fatigue, all while allowing the participant to meet their personal mobility goals.10 The investigators are proposing an innovative study design. Assessing changes in muscle spasticity using electromyography and the Modified Ashworth scale before and after each portion of our two-pronged intervention will enable them to understand the immediate effects of dry needling, as well as the combined effects of function electrical stimulation with with treadmill training. Following the intervention assessments with pre-post functional tests will allow us to determine long term changes. This proposal offers a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with the advantage of being minimally invasive and inexpensive. Results of this pilot study will inform the potential use in MS, and will allow for a larger study examining optimal intervention parameters for future use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS with spasticity of one lower extremity | – | Other: dry needlingA person diagnosed with Multiple Sclerosis and spasticty of one lower extremity. The person must be able to walk 25 feet and cannot have had Botox in the lower extremity on the last 6 months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People with a diagnosis of MS and spasticity
Key inclusion criteria (3 listed)
- Diagnosis of MS based on MRI
- Ability walk 25 feet
- Spasticity of one lower extremity
Key exclusion criteria (4 listed)
- Blood clot within the last 6 months
- Bleeding disorder
- Active cancer
- Botox in the lower extremities within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingAlso: functional electrical stimulationdry needling followed by functional electrical stimulation and treadmill training | Other | MS with spasticity of one lower extremity |
Primary outcome
6 minute walk test
Time frame: up to 7 weeks
distance walked over 6 minutes assessed at the start of the study and after 6 weeks.
25-foot walk
Time frame: up to 7 weeks
time to walk 25 feet assessed at the start of the study and after 6 weeks.
Berg Balance Scale
Time frame: up to 7 weeks
Balance test conducted at the start of the study and after 6 weeks.
Modified Fatigue Impact Scale
Time frame: up to 7 weeks
patient-reported questionnaire collected at the start of the study and after 6 weeks.
Toe taps on force plate
Time frame: up to 7 weeks
number of toe taps in 10 seconds counted at the start of the study and after 6 weeks.
EMG data of both lower extremities
Time frame: up to 7 weeks
Electromyography (EMG) will be conducted at the start of the study and after 6 weeks. EMG is an electrodiagnostic technique for evaluating and recording the electrical activity produced by skeletal muscles. This is completed using electrodes that are placed on the skin, which detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. These action potentials are measured and recorded on a computer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley James, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: up to 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.